77次体外诊断试剂生产企业体系考核766条缺陷项的原因分析

Cause Analysis of 766 Deficiency during the Evaluation of the Manufacturer of 77 In Vitro Diagnosis Reagent

目的：通过对体外诊断试剂生产企业体系考核中缺陷项的原因分析,为体外诊断试剂生产企业今后生产中需要注意的事项以及检查员应关注的方向提供参考。方法：实行《体外诊断试剂生产企业质量体系考核实施规定（试行）》之后对被检查企业的缺陷项进行统计分析。结果：77次体外诊断试剂生产企业体系考核766条缺陷项,涉及127个条款,占82%。结论：关注缺陷项的原因分析,能够有效控制体外诊断试剂产品的质量,不断提高体系考核的通过率和检查员的工作效率。

Objective：By analyzing the cause of deficiency during the evaluation of the manufacturer of 77 In Vitro Diagnosis（IVD）reagent,provide the IVD reagent manufacturer and inspector with reference on points for attention.Methods：Statistical analysis on the deficiency of inspected manufacturer after the execution of Regulation of Quality Evaluation of IVD Reagent Manufacturer（Test）.Results：Among the 766 deficiencies evaluated on 77 IVD reagent manufacturer,127 causes is covered,accounting for 82%.Conclusion：Focus on the analysis of causes for deficiency,improve the quality of IVD reagent,increase the percent of pass of system evaluation and efficiency of inspector.